When Recipients of the Stryker Rejuvenate and Stryker ABGII Hip Implant Develop Pseudotumors

While the term “pseudo tumor” was first used in reference to neurological tumors, the advent of the metal hip implant has expanded the use of the term to describe a generally non-infectious, non-cancerous, space-occupying tumor in the hip region. Metal hip implants have suffered heavily in the past couple of years with recalls, safety concerns and lawsuits abounding. The National Joint Registry of England and Wales indicated that one out of every eight patients who had received the recalled DePuy ASR system were required to undergo revision surgery within five years due to adverse health issues. Stryker Orthopedics has experienced its own troubles regarding their Rejuvenate and ABGII hip implant devices, with both of those implants being recalled in July, 2012. Stryker sent out an Urgent Safety Alert to physicians and hospitals earlier in April of 2012, and issued a recall in Canada in May—proving once again that Canada appears to routinely be ahead of the curve regarding potentially harmful medical devices and drugs.

Do Metal-on-Metal Hip Implants Lead to Pseudo Tumors?

The safety alert issued by Stryker made no mention of pseudo tumors however PR Web states that recent research reveals that those “who have received large-diameter metal-on-metal hip implants…may face a significant risk of developing pseudo tumors.” The article goes on to say that research done in the Netherlands found “recipients of metal-on-metal hip implants had a four times increased risk of developing a pseudo tumor if they presented with elevated serum metal ion levels.” Pseudo tumors which are seen in recipients of a metal hip implant are thought to be a hypersensitive reaction to microscopic metal shards and, generally speaking, patients who develop pseudo tumors must undergo surgery to replace the metal hip device with a ceramic or polyethylene device. In fact, Andrew Sullo, Managing Partner of Sullo & Sullo, a products liability law firm based in Houston, Texas, believes that evidence of a pseudo tumor plus pain may generally equal the necessity of revision surgery.

Potential Symptoms of Pseudo Tumors

Recipients of metal hip implants may have specific symptoms related to pseudo tumors or may be unaware of the tumor until it has grown quite large. Depending where the pseudo tumor is located and how large it has grown, the patient may experience unexplained hip or groin pain, a clicking or popping noise, swelling in the upper leg or even in the foot and ankle region, an easily discernible lump in the hip region, a fracture of the hip or nerve palsy- a nerve disorder that causes weakness or immobility. Stryker mentioned in their safety alert that the Rejuvenate and ABGII had the potential of causing excessive metal debris, corrosion and fretting. That metal debris can be responsible for lesions or pseudo tumors in the hip region. These pseudo tumors can grow quite rapidly, becoming larger than an orange. The pseudo tumor can be accompanied by excessive bone loss and mild to serious levels of pain. In some cases pseudo tumors can put pressure on surrounding structures leading to further adverse health issues.

The Seriousness of Pseudo Tumors

Medical literature notes that when opened up during surgical procedures some of the pseudo tumors have been known to literally explode. It is important for recipients of metal hip implants to remember that while pseudo tumors are serious and can lead to a potentially dangerous revision surgery they are not a hidden form of cancer or even a pre-cancerous condition. A site called hipresurfacingsite.com states that pseudo tumors are possible whether the implant is metal, ceramic or plastic, however most studies indicate that metal hip devices are more likely to cause pseudo tumors due to the metal particles which shear away during periods of activity. It does appear that there is little tolerance for positioning errors in metal hip implant devices particularly among smaller-boned women who may have shallower hips. The margin for error in these cases is relatively slim, meaning pseudo tumors may be more likely to develop.

Detecting the Pseudo Tumor

In those who developed pseudo tumors it was noted that very subtle changes in progressive x-rays might have been an indication of the pseudo tumor. When patients present with groin or hip pain or other potential symptoms of pseudo tumors their physician may advise that further x-rays, blood tests and possibly a multi-slice CT scan to determine whether a pseudo tumor is present. In some cases aspiration of the hip joint may be warranted as a method of excluding the presence of infection.

Risks of Revision Surgery

While revision surgery may be advised should pseudo tumors be present, the surgery itself is not without risk. There are particular challenges for surgeons who must remove the ABGII or the Rejuvenate due to the fact that the devices are typically implanted deeply into the femoral bone. Removal of the device can be very tricky, and the surgery typically takes from 4-5 hours to complete. Because of the extra time the surgery requires, patients may experience infection, excessive blood loss or nerve damage. Most revision surgery patients note that their recovery time is significantly longer than the recovery time for their first hip implant. Revision surgery patients may also experience more dislocation of the hip joint simply because there is much less bone available with which to attach the new implant. The femur may also be broken during the surgery as the surgeon attempts to “dig out” the defective device.

Getting Assistance

While most hip implants are reasonably expected to last from 10-15 years, many metal hip implants have failed after only a few short years—or sooner. The Rejuvenate received FDA approval in June of 2008 while the ABGII was approved in November of 2009. Problems arose with these two hip implant devices relatively quickly and those who have been implanted with a Stryker Rejuvenate or ABGII should make an appointment with their physician at the earliest date possible – whether or not they have yet experienced adverse health issues. After visiting with a physician, an appointment with a knowledgeable legal professional may also be warranted. 

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